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临床试验/NCT06437236
NCT06437236招募中不适用

Comparative Study Between Intravenous Granisetron and Ondansetron on Their Effect on Hemodynamics and Shivering After Spinal Anesthesia in Elective Cesarean Delivery : A Randomized Double-Blind Study

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Blood pressure mesurment in mmhg

研究概览

简要总结

Spinal anesthesia is commonly used in cesarean section surgeries . The most important adverse effects of spinal anesthesia are hypotension and bradycardia caused by sympathetic blockade, with an incidence of about 55-100% . However, blocking the venous return by the gravid uterus increases the risk of hypotension. Spinal anesthesia-induced hypotension is commonly associated with uncomfortable symptoms, such as shivering , nausea and vomiting, in the mother. Prolonged maternal hypotension may lead to serious maternal adverse effects, such as cardiovascular collapse, loss of consciousness, apnea, and aspiration of gastric contents. In addition, uteroplacental blood flow decreases in cases of sustained hypotension and detrimental neonatal effects, such as fetal acidosis and fetal death, may occur. Preventing spinal anesthesia-induced hypotension during cesarean section is essential for the well-being of both the mother and neonate.

Also, Shivering often happens after spinal anesthesia. Shivering is an unconscious and rhythmic movement involving several groups of muscles. The increase of muscle activity generates the elevation of oxygen consumption, lactic acidosis, and carbon dioxide production In recent years, researchers have focused on the effects of the Bezold-Jarisch reflex (BJR) . This reflex includes a triad of bradycardia, hypotension, and apnea. Researchers have suggested that serotonin and 5-hydroxytryptamine 3 (5-HT3) receptors play an important role in the occurrence of the BJR after spinal anesthesia . The 5-HT3 receptors are present in the heart, lung, and spine. Diminished venous return caused by spinal anesthesia stimulates the cardiac chemoreceptors, and parasympathetic activity increases, which results in bradycardia and hypotension . Studies have suggested that the use of 5-HT3 antagonists may attenuate spinal anesthesia-induced hypotension, thus inhibiting peripheral vasodilatation, alleviating the BJR, and increasing venous return to the heart . Ondansetron is a commonly used 5-HT3 receptor antagonist, and its peak plasma concentration occurs within 30 min following IV injection. Granisetron is a new 5-HT3 receptor antagonist, and the onset of action occurs 30 min following its IV administration [

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • All parturient who underwent elective caesarean delivery under spinal anesthesia will be included in this study

排除标准

  • Patient refusal
  • Patient with significant neurological , psychological disease
  • patient known allergy to ondansetron or granisetron,
  • patients receiving serotonin agonists or antagonists,
  • patient ischemic heart disease, chronic hypertension or pregnancy induced hypertension

研究组 & 干预措施

Group A

Active Comparator

will receive ondansetron 4mg diluted in normal saline,The total volume of the solution infused will kept at 10 mL.

After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block.

干预措施: ondansetron (Drug)

group B

Active Comparator

will receive granisetron 1mg diluted in normal saline.The total volume of the solution infused will kept at 10 mL.

After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block.

干预措施: granisetron (Drug)

结局指标

主要结局

Blood pressure mesurment in mmhg

时间窗: 6 months

a comparison of change in Blood pressure among groups

次要结局

  • incidece of shivering or not(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Abdelrady Abdelaziz

resident at Anesthesiology, Surgical Intensive Care and Pain Medicine department

Sohag University

研究点 (1)

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